Events

Recall of Device Recall HeartWare Ventricular Assist System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Heartware.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76600
  • Event Risk Class
    Class 1
  • Event Number
    Z-1538-2017
  • Event Initiated Date
    2017-02-03
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153628
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventricular (assisst) bypass - Product Code DSQ
  • Reason
    Product recall of all hvad controllers currently on the market and to exchange them for the next generation hvad controller (controller2.0).
  • Action
    The firm will release a communication to their consignees stating the following: As a reminder, as with all HVAD Controllers, continue to reinforce the following with your patients and staff at all opportunities: " Patients should continue to have a backup HVAD Controller ready at all times in the event of a primary HVAD Controller failure. " Staff only: The driveline extension cable is to be used during the pre-implant test only. It is not intended to be used after the pump is implanted in the patient. Hospital and Clinician Actions (to be executed in the following order): 1) Review the enclosed notice and forms, and forward the notice to those individuals within your organization who need to be aware of its contents. 2) Complete, sign, and return the Acknowledgement Form to HeartWare within thirty (30) days of receipt of this letter. 4) Quarantine and replace affected HVAD Controllers, DC Adapters, Instructions for Use, Emergency Responder Guides and Patient Manuals in hospital inventory after training is complete. For every patient, quarantine and replace the following under clinical supervision in an environment where appropriate support equipment is readily available: - Primary and Backup HVAD Controller; - Affected DC Adapters; and - Patient Manual and Emergency Responder Guide. Clinicians are reminded not to perform an HVAD Controller exchange during an active electrical fault alarm as the HVAD Pump will be running a single stator. If an electrical fault is present, download patient log files and contact your HeartWare representative to resolve the electrical fault before executing the controller exchange. 5) Return all quarantined HVAD Controllers and DC Adapters to HeartWare. Your HeartWare representative will assist you with this process. 6) Completion Form. Once affected product in inventory has been identified and returned, complete and return the attached Completion Form to CON2.0@heartware.com or your HeartWare representative no late

Device

Device Recall HeartWare Ventricular Assist System
  • Model / Serial
    HeartWare HVAD System Controller Product numbers: 1401US, 1401XX, 1403US, 1407XX, and 1400 with the serial Number(s) lower than CON300000 HeartWare HVAD DC Adapter Product number: 1435  .
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, , Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, UK, and Vietnam.
  • Product Description
    HeartWare HVAD System Controller || The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
  • Manufacturer
    Heartware

Manufacturer

Heartware
  • Manufacturer Address
    Heartware, 14400 NW 60th Ave, Miami Lakes FL 33014-2807
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA